Promotion and PR

WASHINGTON - The FDA last week disclosed that it is working on a guidance document about "the dissemination of press releases by sponsors, or on their behalf, containing information concerning investigational drugs," and asked for public comments on guidance documents relating to drug advertising and labeling.

The agency's announcement in the Federal Register also listed the following topics that are, or may be, the subject of future Division of Drug Marketing, Advertising, and Communications (DDMAC) guidance documents: accelerated approval; direct-to-consumer promotion; drug product promotion at international meetings held in the U.S.; television "infomercials"; promotion on the Internet; and promotion to managed care organizations...